|Trade Name||NOVAFLEX DELIVERY SYSTEM|
|Classification Name||aortic valve, prosthesis, percutaneously delivered|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for implementation of the use of a modified hypotube during the slotted shaft to balloon catheter bonding process for the novaflex+ delivery system.